Method of implanting a penile prosthetic reservoir with concave major surfaces

ABSTRACT

A method of implanting a penile prosthetic in a man includes providing a reservoir having a first major surface separated from to a second major surface by a side wall, the first major surface and the second major surface are both concave and form opposed depressions in the reservoir when the reservoir is empty of liquid. The method additionally includes connecting the reservoir to a pump that is connected to a cylinder, implanting the pump in the scrotum, implanting the cylinder in a corpora cavernosum of the penis, and implanting the reservoir in the man.

BACKGROUND

An implanted penile prosthetic is effective in relieving erectiledysfunction in men.

A penile prosthetic typically includes a cylinder that is implanted ineach corpora cavernosum of the penis, a reservoir implanted in theabdomen that communicates with the cylinders, and a pump, often locatedin the scrotum, that is employed to move liquid from the reservoir intothe cylinders.

In a typical application, the user squeezes a bulb of the pump multipletimes to incrementally draw liquid out of the reservoir, into the bulb,and eventually into the cylinders. The repeated squeezing of the bulbmoves the liquid from the reservoir into the cylinders, whichincrementally deflates the reservoir and incrementally inflates thecylinders to eventually provide the user with an erect penis. The usermay return the penis to its flaccid state by selectively transferringthe liquid from the cylinders back into the reservoir.

The above-described penile prosthetics have proven effective inrelieving erectile dysfunction in men. However, there is a continueddesire for more efficient, discreet, and effective penile prostheses.

SUMMARY

One aspect provides an implantable penile prosthetic including a pumpattachable between a reservoir and a cylinder that is implantable into acorpora cavernosum of a penis. The reservoir has a central longitudinalaxis and includes a wall connected between a first edge of a firstsurface and a second edge of a second surface. The first surface isconcave relative to the first edge and the second surface is concaverelative to the second edge such that each of the first and secondsurfaces form a depression in the reservoir when the reservoir is emptyof liquid. The reservoir expands to contain liquid such that the firstsurface and the second surface are both convex relative to the centrallongitudinal axis.

One aspect provides a method of implanting a penile prosthetic in a man.The method includes providing a reservoir having a first major surfaceseparated from to a second major surface by a side wall, the first majorsurface and the second major surface are both concave and form opposeddepressions in the reservoir when the reservoir is empty of liquid. Themethod additionally includes connecting the reservoir to a pump that isconnected to a cylinder, implanting the pump in the scrotum, implantingthe cylinder in a corpora cavernosum of the penis, and implanting thereservoir in the man.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a perspective view of one embodiment of an implantable penileprosthetic including a reservoir.

FIG. 2 is a side cross-sectional view of the reservoir illustrated inFIG. 1.

FIG. 3 is an end cross-sectional view of the reservoir illustrated inFIG. 1.

FIG. 4 is a top perspective view of the reservoir illustrated in FIG. 1.

FIG. 5 is a bottom perspective view of the reservoir illustrated in FIG.1.

FIG. 5 is a cross-sectional view of the pump in a configuration suitedto pressurize the pressure reservoir illustrated in FIG. 1.

FIG. 6 is a side view of the reservoir illustrated in FIG. 1 when filledwith liquid.

FIG. 7 is a schematic view of the implantable penile prostheticillustrated in FIG. 1 implanted in a man.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

The term “proximal” as employed in this application means that thereferenced part is situated next to or near the point of attachment ororigin or a central point: as located toward a center of the human body.The term “distal” as employed in this application means that thereferenced part is situated away from the point of attachment or originor the central point: as located away from the center of the human body.A distal end is the furthest endmost location of a distal portion of athing being described, whereas a proximal end is the nearest endmostlocation of a proximal portion of the thing being described. Forexample, the glans penis is located distal, and of the crus of the penisis located proximal relative to the male body such that a distal end ofa corpora cavernosum of the patient extends about midway into the glanspenis.

“Liquid” means a substance having molecules that do not disperse suchthat the liquid resists compression and the molecules of the liquid willnot disperse to fill all spaces of a container in which the liquid isdisposed. Saline is an example of a liquid.

In this specification, a “major surface” is a surface of athree-dimensional object that provides the object with most of itssurface area. As an example, a sheet of paper generally has a front sideand a back side with a thin edge thickness between the front and backsides; the front side and the back side are both major surfaces.

In this specification, a reservoir is “filled with liquid” when thereservoir contains some amount of liquid; that is, the reservoir is notempty of liquid. In this specification, a “reservoir expands to containliquid” means that the reservoir flexes to contain some amount of liquidmore than the reservoir contains in its empty state.

Embodiments provide an implantable penile prosthetic having a reservoirthat is provided with a low profile that is unobtrusive to the user. Thereservoir includes opposing concave depressions formed in the majorsurfaces that configure the reservoir with a low profile when implanted.The opposing concave depressions of the reservoir allow the reservoir toexpand comfortably and discreetly when implanted and filled with liquid.When implanted, the reservoir presents such a discreet profile as to benearly imperceptible. Embodiments of the reservoir include differentialconcave surfaces that expand to different extents, which allows thereservoir to expand more inwardly into the body than outwardly, and thiscontributes to its discreet implanted profile.

FIG. 1 is a perspective view of one embodiment of an implantable penileprosthetic 20. The penile prosthetic 20 includes a pump 22 attachable toa penile implant 24 and a reservoir 26. Generally, suitable connectionsare made as the pump 22 is implanted into the scrotum of the user, thepenile implant 24 is implanted into corpora cavernosa of the penis, andthe reservoir 26 is implanted within the abdomen of the user. The penileprosthetic 20 is illustrated in a configuration in which the componentshave been coupled together and the reservoir 26 is not filled withliquid.

The pump 22 includes a bulb 27 that is operable (for example bysqueezing of the bulb 27) to move liquid stored in the reservoir 26 intothe penile implant 24. In one embodiment, the penile prosthetic 20includes a release mechanism 28 associated with the pump 22 that isoperable to hold or “check” the liquid in the penile implant 24 afterthe liquid has been transferred into the penile implant 24. The releasemechanism 28 is configured to be manually operated by the user toselectively release the liquid in the penile implant 24 back to thereservoir 26 through the tube 30, for example when pads 31 on therelease mechanism 28 are pushed. The pump 22 is fabricated from materialsuitable for body implantation, such as silicone, polymers such asurethanes, blends of polymers with urethane, copolymers of urethane, orthe like.

The penile implant 24 includes a pair of inflatable cylinders 32, eachof which is sized to be implanted into a corpora cavernosum of thepenis. Each of the cylinders 32 is connected to the pump 22 by a tube34. Each of the cylinders 32 includes a proximal end 36 opposite adistal end 38. During implantation, the proximal end 36 (also called arear tip) is implanted toward the crus of the penis and the distal end38 is implanted within the glans penis. The cylinders 32 are fabricatedfrom material configured to collapse and be flexible when the cylinders32 are deflated to provide the penis with a flaccid state and expandwhen the cylinders 32 are inflated with liquid to provide the penis withan erect state. Suitable material for fabricating the cylinders 32includes silicone, polymers such as urethanes, blends of polymers withurethane, copolymers of urethane, or the like. Suitable cylinders areavailable from Coloplast Corp., Minneapolis, Minn.

The reservoir 26 includes a neck 40 that is attached to the tube 30. Thereservoir includes a central longitudinal axis CL that projects througha center of the neck 40. The “top” and “bottom” surfaces are majorsurfaces, and each of the major surfaces of the reservoir 26 is concavewhen the reservoir 26 is empty of liquid (as it is first implanted priorto being filled with liquid), which provides the reservoir 26 with a lowprofile. In one embodiment, each of the major concave surfaces isuniformly concave (the major surfaces are equally concave or“bi-concave”). The concave configuration of the major surfaces of thereservoir 26 allows the reservoir 26 to expand a substantial amount whenfilled with liquid (when the cylinders 32 are flaccid). In oneembodiment, the concave major surfaces expand to convex shapes when thereservoir 26 is filled with liquid, which translates the reservoir 26into a nearly cylindrical shape. In one embodiment, the major concavesurfaces are not uniformly concave.

FIG. 2 is a side cross-sectional view of the reservoir 26. The reservoir26 includes an end wall 50 opposite the neck 40. The end wall 50 extendsbetween a first edge 52 of a first surface 54 and a second edge 62 of asecond surface 64. In one embodiment, the first surface 54 is concaverelative to the first edge 52 and the second surface 64 is concaverelative to the second edge 62 such that each of the first and secondsurfaces 54, 64 form a depression in the reservoir 26 when the reservoiris empty of liquid (as illustrated). In one embodiment, the first edge52 and the second edge 62 are substantially planar when the reservoir 26is empty of liquid and the first surface 54 is concave relative to theplanar first edge 52 and the second surface 64 is concave relative tothe planar second edge 62.

In one embodiment, the first surface 54 is equally concave with thesecond surface 64 (“bi-concave”) and the depth of the first surface 54relative to the first edge 52 is substantially equal to the depth of thesecond surface 64 relative the second edge 62.

In one embodiment, the concavity of the first surface 54 is differentfrom the concavity of the second surface 64. In an exemplary embodiment,the first surface 54 has a depth D1 and the second surface 64 has adepth D2, where the depth D2 is greater than the depth D1. In oneembodiment, a radius of curvature for the first surface 54 is less thana radius of curvature for the second surface 64 such that the reservoir26 has major surfaces 54, 64 that have different concavity.

In one embodiment, the first edge 52 and the first surface 54 combine toform a first major surface, and the second edge 62 and the secondsurface 64 combine to form a second major surface, where the majorsurfaces are distinguished over the other surfaces (the end wall 50 andthe neck 40, for example) in that they each have more area than othersurfaces of the reservoir 26.

The side view of FIG. 2 illustrates that the first surface 54 has acurvature that extends between the end wall 50 and the neck 40, wherethe first surface 54 curves about a first transverse axis TA1 that isnot parallel to the central longitudinal axis CL. In a similar manner,the second surface 64 has a curvature that extends between the end wall50 and the neck 40 that curves about a second transverse axis TA2 thatis not parallel to the central longitudinal axis CL.

In one embodiment, the reservoir 26 is fabricated around a mold suchthat the thickness of the end wall 50, the thickness of the neck 40, andthe thickness of the surfaces 54, 64 are substantially equal. The firstsurface 54 and the second surface 64 are configured to be flexible. Withthis in mind, one embodiment of the reservoir 26 provides for thethickness of the first and second major surfaces 54, 64 to be thinnerthan the neck 40 and the end wall 50. Suitable material for fabricatingthe reservoir 26 includes silicone, polymers such as urethanes, blendsof polymers with urethane, copolymers of urethane, or the like. In oneexemplary fabrication process, one of the suitable materials identifiedabove is coated over a mandrel, and when hardened, is peeled off of themandrel to provide the reservoir 26 with the concave first and secondmajor surfaces 54, 64.

FIG. 3 is an end cross-sectional view of the reservoir 26. The reservoir26 includes sidewalls 70 that extend between the first and second majorsurfaces 54, 64. In one embodiment, the sidewalls 70 are generallystraight sidewalls that are parallel with the central longitudinal axisCL. In one embodiment, the sidewalls 70 generally curve between thefirst edge 52 and the second edge 62.

In one embodiment, the first surface 54 is concave and curves about afirst longitudinal axis A1 that is parallel with the centrallongitudinal axis CL, and the second surface 64 is concave and curvesabout a second longitudinal axis A2 that is parallel to both the centrallongitudinal axis CL and the first longitudinal axis A1.

In one embodiment, the first surface 54 is a top surface and the secondsurface 62 is a bottom surface, and the top and bottom surfaces 54, 64each generally curve about a different axis that is parallel to thecentral longitudinal axis CL.

In one embodiment, both of the first and second major surfaces 54, 64are concave and extend between the sidewalls 70 (i.e., laterally) at afirst radius of curvature and extend between the neck 40 and the endwall 50 (i.e., longitudinally as in FIG. 2) with a concavity having asecond radius of curvature. That is to say, each of the first and secondmajor surfaces 54, 64 have a complex concave curvature.

FIG. 4 and FIG. 5 are prospective views of the reservoir 26 empty ofliquid and in a configuration as provided to a surgical facility priorto implantation of the reservoir 26.

FIG. 4 is a top perspective view of the reservoir 26 illustrating thecomplex concave curvature of the first surface 54. The various axes areillustrated to orient the reader; the central longitudinal axis CLextends through a point in an opening of the neck 40, the firstlongitudinal axis A1 is imposed above the reservoir 26 in a longitudinaldirection, the second longitudinal axis A2 is imposed below thereservoir 26 in a longitudinal direction, the first transverse axis TA1is imposed above the reservoir 26 in a transverse direction, and thesecond transverse axis TA2 is imposed below the reservoir 26 in atransverse direction. In one embodiment, when the reservoir 26 is empty,the central longitudinal axis CL extends through a center of the openingof the neck 40.

The first surface 54 includes a first curvature extending between theend wall 50 and the neck 40 that curves about the first transverse axisTA1 and a second curvature extending between the sidewalls 70 thatcurves about the first longitudinal axis A1. In one embodiment, thecomplex curvature of the first surface 54 is contained within the firstedge 52 when the reservoir 26 is empty of liquid. The first edge 52provides a flat surface extending around the perimeter of the reservoir26. The sidewalls 70 and the first and second edges 52, 62 smoothlyblend into the neck 40.

FIG. 5 is a bottom perspective view of the reservoir 26 illustrating thecomplex concave curvature of the second surface 64. The second surface64 includes a first curvature extending between the end wall 50 and theneck 40 that curves about the second transverse axis TA2 and a secondcurvature extending between the sidewalls 70 that curves about thesecond longitudinal axis A2.

Each of the first surface 54 and a second surface 64 has a concavecurvature when the reservoir 26 is empty of liquid. Embodiments providethe reservoir 26 with substantially equal concave curvature on each ofthe first surface 54 and the second surface 64. In one embodiment, thedepth of the curvature of the second surface 64 is deeper than the depthof the curvature of the first surface 54 (FIG. 4) as illustrated in FIG.2.

In one embodiment, the first surface 54 is a top surface, and the secondsurface 64 is a bottom surface that is spaced apart from the top surface54 by a distance equal to a height of the side wall 70, and the top andbottom surfaces 54, 64 each generally curve about a different axis A1,A2, respectively, that is parallel to the central longitudinal axis CL.

FIG. 6 is a side view of the reservoir 26 connected to the pump 22 bythe tube 30 and filled with liquid. When the reservoir 26 is filled withliquid, the reservoir expands away from the central longitudinal axisCL. The first surface 54 expands away from the central longitudinal axisCL by the distance H1 and a second surface 64 expands away from thecentral longitudinal axis by the distance H2. In one embodiment, thedistance H1 is substantially equal to the distance H2. In oneembodiment, the distance H1 is less than the distance H2 and thereservoir 26 expands with a first surface expansion that is differentfrom the second surface expansion. For example, in one embodiment thefirst surface expansion is less than the second surface expansion toallow the reservoir 26 to preferentially expand more in one direction(inward into the patient) than another direction (outward from thepatient). That is, when the reservoir 26 expands, the first surface isless convex than the second surface is convex, relative to the centrallongitudinal axis.

FIG. 7 is a schematic view of the penile prosthetic 20 implanted in aman. The pump 22 is implanted in the scrotum, each of the cylinders 32is implanted into one of the corpora cavernosa, and the reservoir 26 isimplanted within the patient. The pump 22 is connected to the reservoir26 by the tube 30, and the pump 22 is connected to the cylinders 32 bythe tubes 34. After implantation of the prosthetic 20, the surgeon willevaluate function by filling the reservoir 26 with an amount of liquid,for example between 50-350 mL. Thereafter, the function of theprosthetic 20 is evaluated for inflation and deflation of the cylinders32 and for an absence of leaking from the reservoir connections. Thesurgeon confirms acceptable performance of the prosthetic 20 prior toclosing the surgical site.

In one embodiment, the reservoir 26 is implanted in the space of Retziusbehind the symphysis pubis. Thus, one acceptable location forimplantation of the reservoir 26 is behind the pubic bone.

In one embodiment, the reservoir 26 is implanted in the abdomen betweenmuscle and fascia. For example, in one embodiment the reservoir 26 isimplanted in front of the puborectalis muscle and behind thetransversalis fascia. The concave curvature of the first and secondsurfaces 54, 64 provides the reservoir 26 with a compact (or flat)profile configured for discreet implantation into the wall of theabdomen.

In one embodiment, the reservoir 26 is implanted subcutaneously anteriorthe fascia, one example of which is anterior to the transversalisfascia.

In one embodiment, the reservoir 26 is implanted subcutaneously anteriorto the abdominal muscle, one example of which is anterior to thepuborectalis muscle.

In one embodiment, the reservoir 26 is configured to providedifferential expansion such that one of the major surfaces 54, 64expands outward from the central longitudinal axis CL to a greaterextent than the other major surface. As illustrated in FIG. 7, thesecond major surface 64 (FIG. 6) is configured to expand more than thefirst major surface 54, and the second major surface 64 is oriented toface posterior the patient such that the first major surface is orientedto face anterior the patient. When the reservoir 26 expands, the secondmajor surface 64 expands inward into the user to reduce perception ofthe implanted reservoir, thus allowing the implanted reservoir 26 to bediscreet even if implanted near the surface of the skin.

Embodiments provide a reservoir having opposing concave depressionsformed in the major surfaces that configure the reservoir with a lowprofile when implanted. The opposing concave depressions of thereservoir allow the reservoir to expand comfortably and discreetly whenimplanted and filled with liquid. Embodiments of the reservoir includedifferential concave surfaces that expand different amounts thatconfigure the reservoir to expand more inwardly into the body thanoutwardly, for example, and this contributes to its discreet implantedprofile.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

1. A method of implanting a penile prosthetic in a man, the methodcomprising: providing a reservoir comprising a first major surfaceseparated from to a second major surface by a side wall, the first majorsurface and the second major surface are both concave and form opposeddepressions in the reservoir when the reservoir is empty of liquid;connecting the reservoir to a pump that is connected to a cylinder;implanting the pump in the scrotum; implanting the cylinder in a corporacavernosum of the penis; and implanting the reservoir in the man.
 2. Themethod of claim 1, wherein the side wall is connected between a firstedge of the first major surface and a second edge of the second majorsurface, with the first major surface concave relative to the first edgeand the second major surface concave relative to the second edge.
 3. Themethod of claim 2, wherein a height of the wall is configured such thatthe first major surface is separated from the second major surface byless than one inch.
 4. The method of claim 1, wherein implanting thereservoir in the man comprises implanting the reservoir between muscleand fascia in an abdomen of the man.
 5. The method of claim 4, whereinimplanting the reservoir between muscle and fascia in an abdomen of theman comprises implanting the reservoir anterior to a puborectalis muscleand posterior to transversalis fascia.
 6. The method of claim 1, whereinimplanting the reservoir in the man comprises implanting the reservoirsubcutaneously anterior to transversalis fascia.
 7. The method of claim1, wherein implanting the reservoir in the man comprises implanting thereservoir subcutaneously anterior to abdominal muscle.